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The Effect of Inhaled Lavender and Bergamot Oil on Anxiety and Sleep Quality in Intensive Care Patients.

I

Istanbul University - Cerrahpasa (IUC)

Status

Completed

Conditions

Patient Undergoing Surgery

Treatments

Other: aromatherapy
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05692700
E-95961207-604.01.01-1535

Details and patient eligibility

About

This study was carried out as a randomized controlled experimental study to determine the effect of inhaled lavender and bergamot oil on anxiety and sleep quality in patients hospitalized in the intensive care unit who had undergone surgical intervention.

The universe of the research; Patients who were hospitalized in an Intensive Care Unit in Istanbul between May 2021 and October 2021, and the sample consisted of patients who met the criteria for inclusion in the study. Fifty-four patients who agreed to participate in the study and met the inclusion criteria were included. Lavender oil or bergamot oil or distilled water was administered to the patients 2 evenings by inhalation.

Full description

The universe of the research; Patients who were hospitalized in the Intensive Care Unit of a university hospital in Istanbul between May 2021 and October 2021, and the sample consisted of patients who met the inclusion criteria of the study. Data collection started after obtaining the ethics committee permission, institutional permission, and research permission from the Ministry of Health GETAT Clinical Research Department. A simple computer-assisted randomization method was used to distribute the groups homogeneously. Fifty-four patients who were hospitalized in the reanimation intensive care unit and accepted to participate in the study and met the inclusion criteria were included. The patients were randomly assigned to 3 groups of 18 people, each with distilled water, lavender oil, and bergamot oil. "Patient Information Form", "Patient Follow-up Form", "State-Trait Anxiety Inventory" and "Richard-Campbell Sleep Scale (RCUS)" were used to collect data.

Enrollment

54 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Over 18 years old and under 70 years old.
  • Staying in the intensive care unit for at least 3 nights after surgery.
  • Ability to communicate ("Richmond Agitation Sedation Scale" +1, 0, -1 points).
  • Glasgow coma scale score of 9 or higher.

Exclusion criteria

  • Having pain.
  • Having any problems with smelling.
  • The need for mechanical ventilation.
  • Systolic blood pressure below 100 mm Hg.
  • Having lung cancer, asthma and chronic obstructive pulmonary disease.
  • Having allergies to known plants, flowers and related essential oils.
  • Using any medication for anxiety and sleep problems.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 3 patient groups, including a placebo group

Aromatherapy lavender group
Experimental group
Description:
Stage 1: Patient information form, follow-up form, State Continuity Anxiety Scale, Richard-Campbell Sleep Scale were filled.Stage 2: On the second day of the surgery, at 20:00 in the evening, they were asked to inhale 2-3 drops of lavender essential oil, which was dripped onto the pillow pouches, at 21:00, and these bags were placed 10 cm away from the patient after 20 minutes. These bags were taken from the bedside of the patient at 08:00 in the morning.. Stage 3: Before the evening application, the patient follow-up form, State-Continuity Anxiety Scale, Richard Campbell Sleep Scale were filled and they were asked to inhale 2-3 drops of lavender essential oil, which was dropped on the pillow bags prepared at 20:00, and inhaled at 21:00. Afterwards, these sacs were placed 10 cm away from the patient. These sacs were taken from the bedside of the patient at 08:00 in the morning and the patient follow-up Form, State-Trait Anxiety Scale, Richards-Campbell Sleep Scale were filled
Treatment:
Other: aromatherapy
Aromatherapy bergamot group
Experimental group
Description:
Stage1:Patient information form, follow-up form, State Continuity Anxiety Scale, Richard Campbell Sleep Scale were filled. Stage 2:On the second day of the surgery, at 20:00 in the evening, they were asked to inhale 2-3 drops of bergamot essential oil, which was dripped onto the pillow pouches,at 21:00, and these bags were placed 10 cm away from the patient after 20 minutes. These bags were taken from the bedside of the patient at 08:00 in the morning.Stage 3:Before the evening application, the patient follow-up form, State-Continuity Anxiety Scale, Richard Campbell Sleep Scale were filled and they were asked to inhale 2-3 drops of bergamot essential oil, which was dropped on the pillow bags prepared at 20:00, and inhaled at 21:00. Afterwards, these sacs were placed 10 cm away from the patient.These sacs were taken from the bedside of the patient at 08:00 in the morning and the patient follow-up Form, State-Trait Anxiety Scale, Richards-Campbell Sleep Scale were filled.
Treatment:
Other: aromatherapy
Plasebo group
Placebo Comparator group
Description:
Stage 1:Patient identification form, follow-up form, State Continuity Anxiety Scale, Richard Campbell Sleep Scale were filled in.Stage2: 2-3 drops of distilled water dripped onto the prepared pillow bags at 21:00 on the second and third days of the surgery by inhalation. They were asked to breathe and after 20 minutes, these sacs were taken and placed 10 cm away from the patient.Stage 3:These sacs were taken from the bedside of the patient at 08:00 in the morning and the patient follow-up form, State-Trait Anxiety Scale, Richards Campbell Sleep Scale were filled again.
Treatment:
Other: Placebo

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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